This is a single-center, randomized, double blind controlled study to investigate the effects of Bifidobacterium, BB-12® versus placebo in a study group of pediatric patients with infantile colic.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
80
Dipartimento di Scienze Mediche Traslazionali - Sezione Pediatria - Università degli Studi di napoli "Federico II"
Naples, Italy
Number of Participants With >=50% Reduction in Mean Weekly Crying Duration
Treatment success rate was evaluated in terms of reduction of crying duration, comparing mean weekly duration of the last Week (from T4 to T5) and mean weekly duration of Week 1 (from T0 to T1). The daily number and duration of crying episodes has been collected in the 'Evaluation of crying' section of the patient diary. Weekly mean is defined as the mean of the calculated average daily durations during the selected week and is described by means of descriptive statistics for continuous data. Mean changes from baseline (i.e. mean of the first Week) to the mean of the selected week will be computed as well. The following categories of patients has been defined: Success = patients who meet the criteria for the treatment success rate No Success = patients who do not meet the criteria for the treatment success rate Missing = patients who did not do the last visit (Visit T5 - at 28 days from baseline)
Time frame: at 28 days from the baseline (Visit T5)
Number of Crying Episodes
Weekly mean of cries will be defined as the mean number of cries reported in the "Evaluation of behavior" section during the week (i.e. number of episodes/number of days with episodes) and will be described by means of descriptive statistics for continuous data. Mean changes from baseline (i.e. mean of the first Week) to the mean of the selected week will be analyzed too.
Time frame: at 7 days (Visit T1 - baseline) and 28 days from the baseline (Visit T5)
Infectious Diseases Incidence
Number of infections in respiratory system, gastrointestinal system, urinary tract and skin. An infection was defined as an Adverse Event with SOC equal to "Infections and Infestations".
Time frame: at each visit, for 5 weeks starting from the enrollment in the study (Visit T0, T1, T2, T3, T4 and T5)
Bowel Evacuation - Stool Frequency
Daily frequency of bowel evacuation. The frequency of stools were collected daily in the diary. Stool frequency was evaluated as the mean of total daily stools reported per week.
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Time frame: at each weekly visit from baseline (Visit T1, T2, T3, T4 and T5)
Bowel Evacuation - Stool Consistency
Stool consistency was evaluated as the number and the proportion of patients who reported at least one stool sample of each type per week, according to Bristol scale as follows: Type A = separate hard lumps, like nuts (hard to pass) Type B = sausage-shaped, but lumpy Type C = Like a sausage but with cracks on its surface Type D = like a sausage or snake, smooth and soft Only a descriptive statistics Type E = soft blobs with clear-cut edges (passed easily) Type F = fluffy pieces with ragged edges, a mushy stool Type G = watery, no solid pieces (entirely liquid). Patients could report more than one stool consistency per day then the sum of the "Count of Participants" for each group at each visit could be Greater then the "Overall Number of Participants Analyzed"
Time frame: at each weekly visit from baseline (Visit T1, T2, T3, T4 and T5)
Infant's Mood
The infant's mood (calm, asleep, agitated, irritable) was collected daily in the diary and was evaluated as the number and the proportion of infants who reported at least one mood of each type per week. Patients could report more than one mood per day then the sum of the "Count of Participants" for each group at each visit could be greater then the "Overall Number of Participants Analyzed".
Time frame: at each weekly visit from baseline (Visit T1, T2, T3, T4 and T5)
Infant's Sleep
Duration of sleep (in minutes) was collected daily in the diary during the entire study period. Mean daily duration of sleep by week was defined as the mean of the daily durations during the selected week and was described by means of descriptive statistics for continuous data.
Time frame: at each weekly visit from baseline (Visit T1, T2, T3, T4 and T5)
Infant's Temper
Duration of temper episodes (in minutes) was collected daily in the diary during the entire study period. Mean daily duration of temper episodes by week was defined as the mean of the daily durations during the selected week and was described by means of descriptive statistics for continuous data.
Time frame: at each weekly visit from baseline (Visit T1, T2, T3, T4 and T5)
Infant's Feeding
Duration of feeding (in minutes) was collected daily in the diary during the entire study period. Mean daily feeding time by week was defined as the mean of the daily durations during the selected week and was described by means of descriptive statistics for continuous data.
Time frame: at each weekly visit from baseline (Visit T1, T2, T3, T4 and T5)
Calprotectin
Evaluation of calprotectin levels in fecal samples
Time frame: at 7 days (Visit T1 - baseline) and 28 days from the baseline (Visit T5)
Beta-defensin Type 2
Evaluation of Beta-defensin type 2 levels in fecal samples
Time frame: at 7 days (Visit T1 - baseline) and 28 days from the baseline (Visit T5)
LL37 Peptide
Evaluation of LL37 peptide levels in fecal samples
Time frame: at 7 days (Visit T1 - baseline) and 28 days from the baseline (Visit T5)
Short Chain Fatty Acids - Butyrate
Evaluation of Butyrate levels in fecal samples
Time frame: at 7 days (Visit T1 - baseline) and 28 days from the baseline (Visit T5)
Secretory Immunoglobulin A (SIgA)
Secretory immunoglobulin A (SIgA) levels in fecal samples
Time frame: at 7 days (Visit T1 - baseline) and 28 days from the baseline (Visit T5)